U.S. patent number 10,987,050 [Application Number 15/323,356] was granted by the patent office on 2021-04-27 for system and method for laparoscopic nerve identification, nerve location marking, and nerve location recognition.
This patent grant is currently assigned to ProPep Surgical, LLC. The grantee listed for this patent is ProPep Surgical, LLC. Invention is credited to Jann Bonfils-Rasmussen.
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United States Patent |
10,987,050 |
Bonfils-Rasmussen |
April 27, 2021 |
System and method for laparoscopic nerve identification, nerve
location marking, and nerve location recognition
Abstract
A method and system for nerve identification, monitoring,
location marking, and location recognition system used during
laparoscopic surgery.
Inventors: |
Bonfils-Rasmussen; Jann
(Leander, TX) |
Applicant: |
Name |
City |
State |
Country |
Type |
ProPep Surgical, LLC |
Austin |
TX |
US |
|
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Assignee: |
ProPep Surgical, LLC (Austin,
TX)
|
Family
ID: |
1000005518490 |
Appl.
No.: |
15/323,356 |
Filed: |
July 20, 2015 |
PCT
Filed: |
July 20, 2015 |
PCT No.: |
PCT/US2015/041213 |
371(c)(1),(2),(4) Date: |
December 30, 2016 |
PCT
Pub. No.: |
WO2016/014444 |
PCT
Pub. Date: |
January 28, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170150923 A1 |
Jun 1, 2017 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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62027130 |
Jul 21, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
90/361 (20160201); A61B 90/39 (20160201); A61B
1/3132 (20130101); A61B 1/00009 (20130101); A61B
1/00045 (20130101); A61B 18/1206 (20130101); A61B
5/389 (20210101); A61B 34/30 (20160201); A61B
5/4893 (20130101); A61B 5/6877 (20130101); A61B
90/37 (20160201); A61B 1/04 (20130101); A61B
2090/363 (20160201); A61B 2090/3937 (20160201); A61B
2034/302 (20160201); A61B 18/1482 (20130101); A61B
2034/2065 (20160201); A61B 2018/00839 (20130101); A61B
2090/3612 (20160201); A61B 2018/00642 (20130101); A61B
2090/364 (20160201); A61B 2018/00595 (20130101); A61B
2090/368 (20160201) |
Current International
Class: |
A61B
1/00 (20060101); A61B 1/313 (20060101); A61B
5/00 (20060101); A61B 18/12 (20060101); A61B
1/04 (20060101); A61B 34/30 (20160101); A61B
90/00 (20160101); A61B 34/20 (20160101); A61B
18/14 (20060101); A61B 18/00 (20060101) |
Field of
Search: |
;600/554 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Science Daily, "Nerve Mapping Technology Improves Surgery for
Compressed Nerves," Science Daily, Mar. 23, 2013, 2 pages,
https://www.sciencedaily.com/releases/2013/03/130323152444.htm.
cited by applicant .
The Neurosurgery Spine Center, "Nerve Mapping," Dec. 5, 2017, 3
pages, https://www.neurosurgeryspinecenter.com/nerve-mapping/.
cited by applicant .
Raymond P. Onders, et al., "Mapping the phrenic nerve motor point:
The key to a successful laparoscopic diaphragm pacing system in the
first human series," Department of Surgery, University Hospitals of
Cleveland, Cleveland, Ohio, Oct. 2004, 8 pages. cited by
applicant.
|
Primary Examiner: Newton; Alexander L
Assistant Examiner: Boler; Rynae
Attorney, Agent or Firm: Trop, Pruner & Hu, P.C.
Claims
The invention claimed is:
1. A nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery
comprising: a) an optical element connected to a camera; b) at
least one recording electrode probe; c) a surgical instrument for
use as an exploratory probe; d) an analyzer in operable
communication with the at least one recording electrode; the
analyzer operable to indicate a proximity of the exploratory probe
to the nerve based on a strength of an electrical signal sensed by
the at least one recording electrode; the strength of the
electrical signal being displayed on a monitor and being sensed by
a criteria gate; e) an image capture and digital marker system that
is activated by the criteria gate and sets and stores a digitally
generated marker at the location of an identified nerve in the
surgeon's visual field; and f) an image control processor that
sends a stored image to be displayed on a monitor; and g) an image
recognition processor with image recognition software that
recognizes the image on a monitor of the surgeon's visual field
when the visual marker of the nerve was generated and redisplays
the stored image of the marker of an identified nerve at its
location on a monitor when the image appears in the monitor.
2. The nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery of
claim 1 wherein the laparoscopic surgery is manual.
3. The nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery of
claim 1 wherein the laparoscopic surgery is robotic.
4. The nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery of
claim 3 that includes a position recognition processor operating
position recognition software that stores the position of the
optical element when the visual marker of a nerve is first
generated and, upon activation of a recall switch, returns the
optical element to that position and redisplays the stored image of
the marker of the identified nerve at its location on the
monitor.
5. The identification, monitoring, location marking, and location
recognition system used during laparoscopic surgery of claim 4
where the monitor is the surgeon's viewfinder of a robotic surgical
device.
6. The nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery of
claim 1 wherein said surgical instrument also functions as an
electro cautery instrument.
7. The nerve identification, monitoring, location marking, and
location recognition system used during laparoscopic surgery of
claim 4 further comprising a control switch in operable
communication with said analyzer, an electro cautery generator and
said surgical instrument, to thereby permit an operator of said
system to selectively alternate use of said surgical instrument
between use as a electro cautery instrument and use as an
exploratory probe.
8. A method for nerve identification, location marking, and
location recognition during laparoscopic surgery comprising: a)
providing an optical element connected to a camera; b) providing a
surgical instrument for use as an exploratory probe; c) providing
at least one electrode probe inserted into a body cavity through a
surface of the body, the at least one electrode probe being
operable to couple to muscle tissue within the body cavity; d)
introducing an electrical signal via the surgical instrument
operating as an exploratory probe to the body within the body
cavity along a presumed pathway of a nerve, thereby selectively
creating an electrical potential received by the at least one
electrode probe coupled to the muscle tissue within the body
cavity; e) analyzing and displaying the electrical potential; f)
observing and evaluating data with an analyzer to determine a
location of the nerve; g) capturing an image of the pathway of the
nerve; h) generating a visual marker of the pathway and displaying
and storing the image for future reference; i) saving the exact
positioning of the optical element during the procedure allowing a
return to the same exact position through image recognition; and j)
presenting the visual marker of the pathway upon returning to the
same exact position.
9. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 8 wherein
the laparoscopic surgery is manual.
10. The method for nerve identification, location marking, and
location recognition during manual laparoscopic surgery of claim 9
wherein: in response to manually returning the optical element to
the position it was in when the nerve was marked and the image was
stored, the method includes recognizing an image that matches the
stored image; in response to (a) recognizing that the image matches
the stored image and (b) activating a re-display switch, the method
includes restoring the digitally generated marker of the identified
nerve on a monitor.
11. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 8 wherein
the laparoscopic surgery is robotic and the optical element is
returned to the position it was in when the nerve was marked and
the image was stored by use of a recall switch.
12. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 11
wherein the activation of the recall switch restores the digitally
generated marker of the identified nerve on a monitor.
13. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 12
wherein the monitor is the surgeon's viewfinder of a robotic
surgical device.
14. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 8 wherein
said surgical instrument also functions as an electro cautery
instrument.
15. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 8 wherein
the laparoscopic surgery is robotic and the optical element is
returned to a magnification setting it had when the nerve was
marked and the image was stored by use of a recall switch.
16. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 11
wherein the laparoscopic surgery is robotic and the optical element
is returned to a magnification setting it had when the nerve was
marked and the image was stored by use of the recall switch.
17. A nerve monitoring system comprising: a) an optical element to
connect to a camera; b) at least one recording electrode probe; c)
a surgical instrument operable as an exploratory probe; d) an
analyzer to communicate with the at least one recording electrode
probe, the analyzer operable to indicate proximity of the
exploratory probe to a nerve based on a strength of an electrical
signal sensed by the at least one recording electrode; e) an image
capture and digital marker system operable to set and store a
digital marker at a location of the nerve in a monitor of the
surgeon's visual field; f) an image recognition processor with
image recognition software operable to: (i) recognize an image that
was present on the monitor when the marker was set, and (ii) when
the image appears in the monitor, redisplay the marker at the
location on the monitor.
18. The system of claim 17 comprising: a recall switch; and a
position recognition processor to store a magnification setting and
position of the optical element when the marker is set and, upon
activation of the recall switch, return the optical element to that
magnification setting and position.
19. The method for nerve identification, location marking, and
location recognition during laparoscopic surgery of claim 8
wherein: the laparoscopic surgery is robotic; in response to use of
a recall switch and during the laparoscopic surgery, the optical
element is returned to the position the optical element was in: (a)
during the laparoscopic surgery, (b) when the nerve was marked, and
(c) when the image was stored; and the position is relative to an
anatomical feature of the patient.
Description
BACKGROUND
Traditionally, surgery on internal body parts is performed by
cutting an incision in the skin to access the internal body parts.
Such open surgery entails a number of known risks including
infection, inadvertent damage to other organs, nerves and other
structures, scarring, and loss of blood. In an effort to reduce
some of these risks and improve patient outcomes surgeons have
developed laparoscopic, and more recently robotic techniques to
perform surgery. Robotic surgery is essentially an advanced type of
laparoscopic surgery in which the arms that enter the body cavity
are robotically controlled instead of manually controlled. During a
laparoscopic or robotic surgery, such as the da Vinci.RTM. surgery
system, small incisions are made in the skin through which 5-12
millimeter access ports are placed. These ports serve as doorways
through which small working instruments and an optical element can
be placed. The optical element/camera creates a magnified view of
the internal organs that the surgeon sees on a monitor or console.
Such less invasive laparoscopic and robotic surgeries typically
have reduced side effects for the patient to allow a more rapid and
complete recovery. They have not, however, substantially decreased
the incidence of intraoperative nerve damage that has been
attributed to post-surgery side effects such as paralysis, erectile
dysfunction, and urinary and fecal incontinence.
This inadvertent nerve damage often occurs because the surgeon
cannot identify the nerves during surgery because they are either
buried in tissue and/or are too small to be seen with the naked eye
or with the magnification typically used during laparoscopic and
robotic surgery. This problem is complicate in laparoscopic and
robotic surgery because not only can the surgeons not see the
nerves but, because their hands are not in the surgical field, they
cannot palpate them either.
This problem of inadvertent nerve damage during surgery gave birth
to the intraoperative neuromonitoring industry over 20+ years ago.
Since that time, intraoperative nerve identification and monitoring
has become standard of care in open surgical procedures in spine,
ENT, vascular and many other surgical specialties. Until recently,
however, intraoperative nerve monitoring was not performed during
laparoscopic or robotic surgery. This changed with the introduction
of the ProPep Nerve Monitoring System. This System allows nerve
identification and nerve monitoring to be performed in real-time
during both robotic-assisted and traditional laparoscopic surgery.
Unfortunately, the system does not "remember" or mark where the
nerves are when the surgeon moves the laparoscopic/robotic optical
element, changing his view of the anatomy. This is cumbersome for
the surgeon and can increase the procedure time as the surgeon has
to reaffirm the location of the nerve throughout a surgical
procedure.
SUMMARY
This application addresses this shortcoming by coupling optical
digital image marking and position and image recognition software
with an intraoperative neuromonitoring system such as the ProPep
Surgical nerve monitoring system.
In a robotic-assisted surgery, the surgeon is "viewing" the tissue
of interest using an optical element connected to a camera. The
system works by allowing the surgeon to digitally "mark" the
location of a nerve in a visual field associated with a specific
location, magnification and orientation of the robotic-assisted
optical element when the surgeon identifies a nerve using an
intraoperative neuromonitoring system. If the surgeon moves the
optical element after "marking" the nerve location in order to
facility some aspect of the surgery, he/she can return the optical
element to the position it was in when the location of the nerve
was "marked" by activating a Recall Switch. This not only returns
the optical element to the original position (via the position
recognition software) but also returns it to the original
magnification and re-displays the nerve location in the surgeon's
visual field.
In a manually operated laparoscopic surgery the system will work in
a similar manner. The surgeon is now manually controlling the
movement of the optical element and will digitally "mark" the
location of a nerve in a visual field after identifying the nerve
with an intraoperative neuromonitoring system. If the surgeon moves
the optical element after "marking" the nerve location in order to
facility some aspect of the surgery, he/she can physically
reposition the optical element to the position it was in when the
location of the nerve was "marked" via the image recognition
software. The surgeon can then use a Re-Display Switch to
re-display the nerve location in the surgeon's visual field.
The shortcoming can also be met by a method for nerve
identification, location marking, and location recognition during
laparoscopic surgery including at least: providing an optical
element connected to a camera; providing a surgical instrument for
use as an exploratory probe; providing at least one electrode probe
inserted into a body cavity through a surface of the body, the at
least one electrode probe being positionable by a surgical
instrument and being operable to couple to muscle tissue within the
body cavity; introducing an electrical signal via the surgical
instrument operating as an exploratory probe to the muscle tissue
within the body cavity along a presumed pathway of a nerve, thereby
selectively creating an electrical potential received by the at
least one electrode probe coupled to the muscle tissue within the
body cavity; displaying the electrical potential; analyzing and
evaluating the electrical potential with the analyzer to determine
the location of the nerve; capturing an image of the pathway of the
nerve; generating and displaying a visual marker of that pathway
and storing that image for future reference; saving the exact
positioning of the optical element when the visual marker was
generated, allowing a return to that exact position through
position or image recognition; and re-displaying the visual marker
of the nerve pathway upon return of the optical element to the
stored position.
The shortcoming can also be addressed by a nerve identification,
monitoring, location marking, and location recognition system used
during laparoscopic surgery including at least: an optical element
connected to a camera and surgeon monitor; at least one recording
electrode probe; a surgical instrument for use as an exploratory
probe; an analyzer in operable communication with the at least one
recording electrode; the analyzer operable to indicate the
proximity of the exploratory probe to the nerve based on the
strength of an electrical signal sensed by the at least one
recording electrode probe; an analyzer monitor to display the
electrical signal sensed; an image capture and digital marker
system activated by a criteria gate that sets and stores a
digitally generated marker at the location of an identified nerve;
an image control processor that sends the stored image to be
displayed on a surgeon monitor; and an position or image
recognition processor operating position or image recognition
software that can store the position of the optical element or the
image of the surgeon's visual field in the surgeon monitor when the
visual marker of the nerves is first generated and redisplay the
digitally generated marker of an identified nerve at its location
on a the surgeon monitor when desired; and a recall or re-display
switch that can return the optical element to the position it was
in when the visual marker was generated or recognize the image in
the surgeon visual field when the optical element is returned to
the position it was in when the visual marker was generated, and
signal the position or image recognition processor to redisplay the
digitally generated marker on the surgeon monitor.
The surgical benefits of using this include the ability for the
surgeon to instantly relocate non-visible nerve tissue marked
earlier during the surgical procedure so as to know what tissue to
spare/not compromise during subsequent surgical intervention and
manipulation.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an overall schematic illustration of the proposed system
and the resultant integration into a robotic-assisted laparoscopic
surgery system.
FIG. 2 is an overall schematic illustration of the proposed system
and the result integration into a manually operated laparoscopic
surgery system.
DETAILED DESCRIPTION
This need, to identify and recall the position of non-visible nerve
tissue during laparoscopic surgery, can be met with the system to
be described below in reference to FIG. 1. In general many of the
elements shown on the left hand side of the drawing are part of the
(modified) ProPep Surgical nerve monitoring system. The description
of the ProPep system is presented in U.S. Pat. No. 8,083,685,
issued on Dec. 7, 2011 and incorporated herein by reference in its
entirety.
In accordance with the present disclosure, a system and method are
provided which substantially reduces the disadvantages and problems
associated with previous methods and systems for identifying
non-visible nerve tissue during robotic-assisted laparoscopic
surgery.
Referring first to FIG. 1 for a robotic surgery system, numeral 320
represents human tissue located within a body cavity containing
non-visible nerve tissue. A dual function laparoscopic surgical
instrument 340 from a robotic surgical system is being used to
perform laparoscopic surgery within the body cavity and to
stimulate tissue. In this context the term dual function refers to
the use of the surgical instrument as either an exploratory probe
used to stimulate tissue or an electro cautery instrument for
surgery. The dual function laparoscopic surgical instrument is
connected to a control switch 150, which in turn is connected to
both an electro cautery generator 170 (power supply) and an
electromyographic analyzer 140. The control switch 150 allows the
surgeon to switch the power going to the surgical instrument 340
between the cauterizing energy from the electro cautery generator
170 needed to perform surgery and the stimulation energy from the
electromyographic analyzer 140 needed to stimulate tissue for the
purpose of identifying and monitoring nerves. The control switch
can be triggered by a foot pedal 160 or any appropriate switch. The
surgeon is aided in these surgical procedures by an optical element
310 protruding into the body cavity and attached to a camera 300.
The optical element facilitates visualization of the laparoscopic
surgical field. This element can take many forms but is in general
a remotely operated endoscopic imaging system with variable
magnification and infinite positioning in 3 dimensional space. It
is controlled by the Optical Element Positioning Device 280 in such
a way as to be able to return to any previous viewing position
through the control of the surgeon. The image information from the
optical element/camera is fed via a Video Data Analyzer 290 to the
surgeon's view finder 260.
There are numerous other elements of the robotic surgery device
that are not shown to simplify the description of the instant
application. A representative description of such a device is shown
in U.S. application 20080065107 A1 (Larkin et. al) published Mar.
13, 2008.
To identify non-visible nerve tissue, two recording electrode
probes 120, one active and one reference and both connected to the
analyzer 140, are inserted through the body surface via a
introducer trocar device and into a body cavity so as to be
accessible by a laparoscopic surgical instrument (not necessarily
the dual function laparoscopic surgical instrument 340) for
placement into muscle tissue 110 wherein the non-visible nerve of
interest 330 terminates. The dual function laparoscopic surgical
instrument 340 switched to stimulation mode is then used to
stimulate the tissue 320 along the presumed nerve pathway. If a
nerve 330 is present in the tissue, the electric current causes a
depolarization of the nerve, which results in a nerve action
potential. The nerve action potential then propagates along the
nerve to the neuromuscular junction (the synapse between the nerve
and the muscle cell) where a neurotransmitter (acetylcholine) is
released in response to the action potential. This neurotransmitter
depolarizes the postsynaptic muscle cells creating an electrical
potential received by the electrode probes 120, analyzed by the
analyzer 140 and displayed as a wave form on the analyzer's display
180, an image of which is sent to electromyography (EMG) Window 275
in the Surgeon's View Finder 260. The relative strength of the
electrical potential received at an electrode probe 120 will
increase as surgical instrument 340 is placed closer to the nerve
330. Thus by moving the surgical instrument 340 along the presumed
nerve pathway, the surgeon maps the actual nerve pathway based upon
the strength of the signal received at electrode probes 120 for
each position of the surgical instrument 340.
As the nerve pathway becomes evident a criteria gate 200 sends
information to an image frame capture system 210, and a digital
image marker generator 220 that provides a visual marker of the
discovered nerve in the surgeon's visual field. In addition the
exact positioning of the optical element 310 at the time of the
digitally generated marker setting is stored by an Optical Element
Position Data Storage 230. An image control processor 240 sends the
image of the surgeon's visual field with the visual markers of the
nerves 190 to be displayed to a Surgical Field Window 270 in the
surgeon's viewfinder 260. Image and Position Recognition Processor
250 manages all of this and stores the image of the surgeon's
visual field and the position of the visual markers of the
nerves.
As surgery proceeds, the surgeon operating the robotic surgical
element may move the optical element of the camera numerous times
but can, at any time, return to the position the optical element
was in when the nerve of interest was mapped by activating a Recall
Switch 195 that signals the Optical Element Positioning Device 280
to pull the position information from the Optical Element Position
Data Storage 230 and position the optical element accordingly. In
one embodiment, clicking on the Surgical Field Window 270 in the
Surgeon's View Finder 260 activates the Recall Switch 195. Once the
Optical Element 310 returns to the position it was in when the
nerve of interest was marked, the Image and Position Recognition
Processor 250 will redisplay the visual marker of the discovered
nerve in the Surgeon View Finder 260 at its location.
In the case of a manually operated laparoscopic surgery, FIG. 2
illustrates a somewhat simpler system in which the surgeon can, at
any time, return to the position the Optical Element 310 was in
when the nerve of interest was mapped by manually moving the
optical element until the image and position recognition software
in the Image and Position Recognition Processor 250 confirms the
real-time image in the Camera 300 matches the image stored in the
Image and Position Recognition Processor 250 of the surgical view
displayed when the nerve of interest was marked. The surgeon then
can re-display the nerve location 190 in surgeon viewfinder 270 by
activating a Re-Display Switch 205.
In practice, the method of this application may be described as
follows. The method works in close conjunction with a robotic
surgery device that has a camera with a positionable optical
element presenting an image of the laparoscopic surgical field. It
provides at least one electrode probe that is inserted into the
body cavity through a surface of the body, the at least one
electrode probe being positionable by a laparoscopic device and
being operable to couple to the body within the body cavity
proximate to a preselected nerve; providing at least one
exploratory probe (dual function laparoscopic surgical instrument
switched to stimulation mode) separate and distinct from the first
at least one electrode probe and adapted to be disposed in the body
cavity; introducing an electrical signal via the exploratory probe
to the body within the body cavity along a presumed pathway of the
nerve of interest thereby depolarizing the tissue surrounding the
nerve which results in an action potential that propagates along
the nerve to the neuromuscular junction (the synapse between the
nerve and the muscle cell) where a neurotransmitter (acetylcholine)
is released in response to the action potential. The
neurotransmitter depolarizes the postsynaptic muscle cells creating
an electrical potential received by the at least one electrode
probe, and providing an analyzer interfaced with the at least one
electrode probe, the analyzer being operable to indicate the
proximity of the at least one exploratory probe to the nerve of
interest based on a measurement of the strength of the electrical
potential signal sensed by the at least one electrode probe;
observing and evaluating the data produced by the analyzer; thus
determining the location of the nerve; generating a visual marker
of that pathway of the nerve and displaying and storing that visual
marker for future reference. The procedure also saves the exact
positioning of the optical element during the procedure, allowing a
return to the same exact position and a re-displaying of the visual
marker image of the nerve pathway.
This combination of improvements enables the surgeon to instantly
locate non-visible nerve tissue marked earlier during the surgical
procedure so as to know what tissue to spare/not compromise during
subsequent surgical intervention and manipulation and to instantly
recall previous marked nerve tissue locations.
Although certain embodiments and their advantages have been
described herein in detail, it should be understood that various
changes, substitutions and alterations could be made without
departing from the coverage as defined by the appended claims.
Moreover, the potential applications of the disclosed techniques is
not intended to be limited to the particular embodiments of the
processes, machines, manufactures, means, methods and steps
described herein. As a person of ordinary skill in the art will
readily appreciate from this disclosure, other processes, machines,
manufactures, means, methods, or steps, presently existing or later
to be developed that perform substantially the same function or
achieve substantially the same result as the corresponding
embodiments described herein may be utilized. Accordingly, the
appended claims are intended to include within their scope such
processes, machines, manufactures, means, methods or steps.
* * * * *
References